Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameEnterra Therapy System
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd., suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS202
Date Received08/03/2021
Decision Date09/01/2021
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for 1) equipment updates in the cea 2-3 silicone molding area (e. G. , six additional ovens), updated option for use of temperature recorder (vaisala monitoring system model vl-1700-54t), updated oven mode for the new ovens to use manual mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (nikon mm-40), 2) an update to the applicable work instructions (wi), and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and factoryworks (fw) updates to support the changes.
-
-